The second Corrigendum to the European Union Medical Device Regulations (EU MDR) (2017/745) has been published by the Council of the European Union. This anticipated Corrigendum delays full transition to MDR for some reclassified devices.
“By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024 provided that from 26 May 2020 it continues…”
Meaning, those devices that did not previously require Notified Body involvement under MDD, but now require Notified Body involvement under MDR, may use the full transition period to transition to MDR. As such, this only applies to Class Ir products under MDR and other formerly Class I products under MDD that are now up-classified into Class II and above under MDR (mostly software).
Article 120(3) also states clearly that the requirements of MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements of AIMD and MDD.
What does this mean for manufacturers?
It may be a small relief to your MDR transition efforts.
For Class 1r and those previously Class I devices under MDD that have been upclassified to Class II or higher
So long as devices’ declarations of conformity are drawn up and signed before May 26, 2020, the second corrigendum states that these products may remain on the EU market until May 26, 2024 provided these devices are subject to the MDR requirements relating to post-market surveillance, market surveillance, vigilance and registration (economic operators and devices) during the transition period.
For Class I devices that continue to be Class I and do not require Notified Body involvement under MDR
These devices must still meet current date of May 26, 2020 for MDR compliance. Therefore, you need to have an MDR Compliant DoC drawn up no later than May 26, 2020.
What should I do now?
- Ensure an updated DoC is drawn up and signed prior to May 26, 2020 – so that you get the full transition period for Class Ir and Up-Classified Devices
- Review prioritization of Class Ir and Up-Classified Devices
- Focus on Class I (non Class Ir or Up-Classified) devices to ensure your Technical Documentation and Clinical Evaluation Reports are incompliance with MDR by May 26, 2020
- Continue (or start) Technical Documentation in compliance with Annex II and Annex III for Class Ir and Up-Classified Class I Devices
- Complete Clinical Evaluation Reports in compliance with MEDDEV 2.7.1/4 for all Class I and Up-Classified Class I devices
- Ensure MDR requirements relating to post-market surveillance, market surveillance, vigilance and registration (economic operators and devices) are in place for all devices.